A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

• Status: Active, not recruiting
• Trial end date: 2022-08-18
• Target enrollment: 0
• Participant gender: All

Summary

This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors

• Melanoma

• Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)

• Gastric adenocarcinoma (includes gastro-esophageal junction)

• Hepatocellular carcinoma (HCC)

• Squamous cell carcinoma of the head and neck (SCCHN)

• Renal cell carcinoma (RCC)

• Bladder cancer

• Participants must have received available standard therapies

• Women and men must agree to follow instructions for method of contraception

• Measureable disease as per RECIST version 1.1 criteria

• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Participants must not have active brain metastases or leptomeningeal metastases

• Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites

• History of allergy or hypersensitivity to study drug components

• Participants with serious or uncontrolled cardiovascular disease

• Excluding patients with serious or uncontrolled medical disorders

• Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment

• Participants with an active, known, or suspected autoimmune disease

• Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Other protocol defined inclusion/exclusion Criteria could apply